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Study of Fluzone® Influenza Virus Vaccines 2012-2013 Formulation Among Adults.

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ClinicalTrials.gov Identifier: NCT01691339
Recruitment Status : Completed
First Posted : September 24, 2012
Results First Posted : November 4, 2013
Last Update Posted : November 4, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation
Biological: Influenza Virus Vaccine: Fluzone® Intradermal 2012-2013 Formulation
Biological: Influenza Virus Vaccine: Fluzone® High-Dose 2012-2013 Formulation
Enrollment 200
Recruitment Details The study participants were enrolled from 19 through 27 September 2012 at 4 clinic centers in the United States.
Pre-assignment Details A total of 200 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.
Arm/Group Title Fluzone® Vaccine (Group 1) Fluzone® Intradermal Vaccine (Group 2) Fluzone® Vaccine (Group 3) Fluzone® High-Dose Vaccine (Group 4)
Hide Arm/Group Description Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
Period Title: Overall Study
Started 50 50 51 49
Completed 50 50 51 49
Not Completed 0 0 0 0
Arm/Group Title Fluzone® Vaccine (Group 1) Fluzone® Intradermal Vaccine (Group 2) Fluzone® Vaccine (Group 3) Fluzone® High-Dose Vaccine (Group 4) Total
Hide Arm/Group Description Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly Total of all reporting groups
Overall Number of Baseline Participants 50 50 51 49 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 51 participants 49 participants 200 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
50
 100.0%
50
 100.0%
0
   0.0%
0
   0.0%
100
  50.0%
>=65 years
0
   0.0%
0
   0.0%
51
 100.0%
49
 100.0%
100
  50.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 51 participants 49 participants 200 participants
43.4  (13.6) 40.5  (14.2) 73.3  (5.7) 72.2  (5.2) 57.4  (18.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 51 participants 49 participants 200 participants
Female
31
  62.0%
29
  58.0%
32
  62.7%
35
  71.4%
127
  63.5%
Male
19
  38.0%
21
  42.0%
19
  37.3%
14
  28.6%
73
  36.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 50 participants 51 participants 49 participants 200 participants
50 50 51 49 200
1.Primary Outcome
Title Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Hide Description

Solicited injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.

Grade 3 injection site: Pain - Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - >100 mm. Grade 3 systemic reactions: Fever ≥39.0°C; Headache, Malaise, Myalgia, and Shivering - significant, prevents daily activity.

Time Frame Day 0 up to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.
Arm/Group Title Fluzone® Vaccine (Group 1) Fluzone® Intradermal Vaccine (Group 2) Fluzone® Vaccine (Group 3) Fluzone® High-Dose Vaccine (Group 4)
Hide Arm/Group Description:
Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
Overall Number of Participants Analyzed 50 50 51 49
Measure Type: Number
Unit of Measure: Participants
Injection site Pain 12 20 12 19
Grade 3 Injection site Pain 0 0 0 0
Injection site Erythema 1 16 0 1
Grade 3 Injection site Erythema 0 0 0 0
Injection site Swelling 1 9 0 1
Grade 3 Injection site Swelling 0 0 0 0
Injection site Induration 1 4 0 1
Grade 3Injection site Induration 0 0 0 0
Injection site Ecchymosis 0 1 0 0
Grade 3 Injection site Ecchymosis 0 0 0 0
Fever 2 0 0 0
Grade 3 Fever 0 0 0 0
Headache 10 12 11 7
Grade 3 Headache 1 1 0 0
Malaise 11 11 10 7
Grade 3 Malaise 0 0 0 0
Myalgia 10 10 13 7
Grade 3 Myalgia 0 0 2 0
Shivering 4 4 4 3
Grade 3 Shivering 0 0 0 0
2.Other Pre-specified Outcome
Title Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Hide Description Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.
Time Frame Day 0 (pre-vaccination) up to Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers against the influenza virus antigens were assessed in the Per-Protocol Analysis Set.
Arm/Group Title Fluzone® Vaccine (Group 1) Fluzone® Intradermal Vaccine (Group 2) Fluzone® Vaccine (Group 3) Fluzone® High-Dose Vaccine (Group 4)
Hide Arm/Group Description:
Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
Overall Number of Participants Analyzed 46 47 49 46
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/H1N1 (Pre-vaccination; N = 46, 46, 49, 46)
28.3
(17.5 to 45.6)
30.7
(18.3 to 51.7)
58.6
(37.5 to 91.6)
81.8
(50.2 to 133)
A/H1N1 (Post-vaccination; N = 46, 47, 49, 46)
1068
(755 to 1512)
1473
(955 to 2269)
246
(177 to 343)
369
(266 to 513)
A/H3N2 (Pre-vaccination; N = 46, 46, 49, 46)
29.1
(18.0 to 47.3)
23.6
(14.3 to 39.0)
68.5
(42.6 to 110)
78.2
(50.2 to 122)
A/H3N2 (Post-vaccination; N = 45, 47, 49, 46)
460
(306 to 691)
599
(369 to 971)
264
(176 to 397)
392
(266 to 578)
B (Pre-vaccination; N = 46, 46, 49, 46)
17.9
(13.0 to 24.6)
20.9
(15.5 to 28.3)
13.7
(10.5 to 17.7)
18.7
(14.4 to 24.3)
B (Post-vaccination; N = 45, 47, 49, 46)
169
(131 to 218)
129
(91.1 to 183)
35.2
(25.8 to 48.1)
60.1
(43.8 to 82.4)
3.Other Pre-specified Outcome
Title Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Hide Description Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroprotection was defined as a pre-vaccination or a post-vaccination titer ≥ 40 (l/dil).
Time Frame Day 0 (pre-vaccination) and Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection against influenza vaccine antigens were assessed in the Per-Protocol Analysis Set.
Arm/Group Title Fluzone® Vaccine (Group 1) Fluzone® Intradermal Vaccine (Group 2) Fluzone® Vaccine (Group 3) Fluzone® High-Dose Vaccine (Group 4)
Hide Arm/Group Description:
Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
Overall Number of Participants Analyzed 46 47 49 46
Measure Type: Number
Unit of Measure: Participants
A/H1N1 (Pre-vaccination; N = 46, 46, 49, 46) 22 23 32 33
A/H1N1 (Post-vaccination; N = 46, 47, 49, 46) 46 46 49 45
A/H3N2 (Pre-vaccination; N = 46, 46, 49, 46) 22 15 33 31
A/H3N2 (Post-vaccination; N = 45, 47, 49, 46) 44 45 46 45
B (Pre-vaccination; N = 46, 46, 49, 46) 9 15 8 13
B (Post-vaccination; N = 45, 47, 49, 46) 45 40 26 33
4.Other Pre-specified Outcome
Title Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Hide Description Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.
Time Frame Day 0 (pre-vaccination) and Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion to the influenza virus vaccine antigens was assessed in the Per-Protocol Analysis Set.
Arm/Group Title Fluzone® Vaccine (Group 1) Fluzone® Intradermal Vaccine (Group 2) Fluzone® Vaccine (Group 3) Fluzone® High-Dose Vaccine (Group 4)
Hide Arm/Group Description:
Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
Overall Number of Participants Analyzed 46 47 49 46
Measure Type: Number
Unit of Measure: Participants
A/H1N1 (N = 46, 46, 49, 46) 43 43 21 26
A/H3N2 (N = 45, 46, 49, 46) 34 39 19 28
B (N = 45, 46, 49, 46) 36 33 13 16
5.Other Pre-specified Outcome
Title Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Hide Description Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay to determine pre-vaccination and post-vaccination titers of <1:10.
Time Frame Day 0 (pre-vaccination) and Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody responses to the influenza vaccine antigens were assessed in the Per-Protocol Analysis Set.
Arm/Group Title Fluzone® Vaccine (Group 1) Fluzone® Intradermal Vaccine (Group 2) Fluzone® Vaccine (Group 3) Fluzone® High-Dose Vaccine (Group 4)
Hide Arm/Group Description:
Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
Overall Number of Participants Analyzed 46 47 49 46
Measure Type: Number
Unit of Measure: Participants
A/H1N1 (Pre-vaccination; N = 46, 46, 49, 46) 18 17 6 6
A/H1N1 (Post-vaccination; N = 46, 47, 49, 46) 0 1 0 0
A/H3N2 (pre-vaccination; N = 46, 46, 49, 46) 17 19 6 2
A/H3N2 (Post-vaccination; N = 45, 47, 49, 46) 0 1 0 0
B (Pre-vaccination; N = 46, 46, 49, 46) 12 9 17 13
B (Post-vaccination; N = 45, 47, 49, 46) 0 1 4 1
Time Frame Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluzone Vaccine (Group 1) Fluzone Intradermal Vaccine (Group 2) Fluzone Vaccine (Group 3) Fluzone High-Dose Vaccine (Group 4)
Hide Arm/Group Description 'Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly' Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
All-Cause Mortality
Fluzone Vaccine (Group 1) Fluzone Intradermal Vaccine (Group 2) Fluzone Vaccine (Group 3) Fluzone High-Dose Vaccine (Group 4)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fluzone Vaccine (Group 1) Fluzone Intradermal Vaccine (Group 2) Fluzone Vaccine (Group 3) Fluzone High-Dose Vaccine (Group 4)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      0/50 (0.00%)      2/51 (3.92%)      0/49 (0.00%)    
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  0/50 (0.00%)  0 0/50 (0.00%)  0 1/51 (1.96%)  1 0/49 (0.00%)  0
Vascular disorders         
Hypertensive crisis * 1  0/50 (0.00%)  0 0/50 (0.00%)  0 1/51 (1.96%)  1 0/49 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Fluzone Vaccine (Group 1) Fluzone Intradermal Vaccine (Group 2) Fluzone Vaccine (Group 3) Fluzone High-Dose Vaccine (Group 4)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/50 (24.00%)      20/50 (40.00%)      13/51 (25.49%)      19/49 (38.78%)    
General disorders         
Injection site Pain  1  12/50 (24.00%)  12 20/50 (40.00%)  20 12/51 (23.53%)  12 19/49 (38.78%)  19
Injection site Erythema  1  1/50 (2.00%)  1 16/50 (32.00%)  16 0/51 (0.00%)  0 1/49 (2.04%)  1
Injection site Swelling  1  1/50 (2.00%)  1 9/50 (18.00%)  9 0/51 (0.00%)  0 1/49 (2.04%)  1
Injection site Induration  1  1/50 (2.00%)  1 4/50 (8.00%)  4 0/51 (0.00%)  0 1/49 (2.04%)  1
Headache  1  10/50 (20.00%)  10 12/50 (24.00%)  12 11/51 (21.57%)  11 7/49 (14.29%)  7
Malaise  1  11/50 (22.00%)  11 11/50 (22.00%)  11 10/51 (19.61%)  10 7/49 (14.29%)  7
Shivering  1  4/50 (8.00%)  4 4/50 (8.00%)  4 4/51 (7.84%)  4 3/49 (6.12%)  3
Musculoskeletal and connective tissue disorders         
Myalgia  1  10/50 (20.00%)  10 10/50 (20.00%)  10 13/51 (25.49%)  13 7/49 (14.29%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01691339     History of Changes
Other Study ID Numbers: GRC50
U 1111-1124-8310 ( Other Identifier: WHO )
First Submitted: September 19, 2012
First Posted: September 24, 2012
Results First Submitted: August 29, 2013
Results First Posted: November 4, 2013
Last Update Posted: November 4, 2013